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To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-03187207 High Dose and Latanoprost Vehicle | Experimental | A single drop of each, once daily in study eye for 28 days |
|
| Latanoprost 0.005% and PF-03187207 Vehicle | Experimental | A single drop of each, once daily in study eye for 28 days |
|
| PF-03187207 Medium Dose and Latanoprost Vehicle | Experimental | A single drop of each, once daily in study eye for 28 days |
|
| PF-03187207 Low Dose and Latanoprost Vehicle | Experimental | A single drop of each, once daily in study eye for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-03187207 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 | Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Diurnal IOP, defined as the mean IOP over the day based on values obtained at 8 AM, 10 AM, 1 PM, and 4 PM, was calculated for each visit. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point. | Baseline, 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ken Harper | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Narashino | Chiba | Japan | |||
| Pfizer Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-0318 0.006% | PF-0318 0.006% once daily in the evening |
| FG001 | PF-0318 0.024% | PF-0318 0.024% once daily in the evening |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Latanoprost 0.005% | Drug |
|
| PF-03187207 Vehicle | Drug | One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207. |
|
| Latanoprost Vehicle | Drug |
|
| Baseline, Day 14, Day 28 |
| Target IOP | Percentage of participants with IOP of 18 mmHg or Lower, 16 mmHg or Lower, or 14 mmHg or Lower at Any Visit Through Day 28. Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point. | Up to 28 days |
| Shimachi |
| Chiba |
| Japan |
| Pfizer Investigational Site | Kawasaki | Kanagawa | Japan |
| Pfizer Investigational Site | Kasukabe | Saitama | Japan |
| Pfizer Investigational Site | Fuji | Shizuoka | Japan |
| Pfizer Investigational Site | Mishima | Shizuoka | Japan |
| Pfizer Investigational Site | Susono | Shizuoka | Japan |
| Pfizer Investigational Site | Hachiōji | Tokyo | Japan |
| Pfizer Investigational Site | Hamura | Tokyo | Japan |
| Pfizer Investigational Site | Minato | Tokyo | Japan |
| Pfizer Investigational Site | Musashino | Tokyo | Japan |
| Pfizer Investigational Site | Setagaya City | Tokyo | Japan |
| Pfizer Investigational Site | Shizuoka | Japan |
| FG002 | PF-0318 0.04% | PF-0318 0.04% once daily in the evening |
| FG003 | 0.005% Latanoprost | 0.005% latanoprost once daily in the evening |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-0318 0.006% | PF-0318 0.006% once daily in the evening |
| BG001 | PF-0318 0.024% | PF-0318 0.024% once daily in the evening |
| BG002 | PF-0318 0.04% | PF-0318 0.04% once daily in the evening |
| BG003 | 0.005% Latanoprost | 0.005% latanoprost once daily in the evening |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 | Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Diurnal IOP, defined as the mean IOP over the day based on values obtained at 8 AM, 10 AM, 1 PM, and 4 PM, was calculated for each visit. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point. | The Per Protocol (PP) population consisted of all subjects in the intention to treat (ITT) population excluding those who made major protocol violations before completing the study. The PP population was considered as the primary analysis population of efficacy (primary and secondary endpoints) of the study. | Posted | Mean | Standard Deviation | mmHg (milimeters of mercury) | Baseline, 28 days |
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| Secondary | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point. | The Per Protocol (PP) population consisted of all subjects in the intention to treat (ITT) population excluding those who made major protocol violations before completing the study. The PP population was considered as the primary analysis population of efficacy (primary and secondary endpoints) of the study. | Posted | Mean | Standard Deviation | mmHg (milimeters of mercury) | Baseline, Day 14, Day 28 |
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| Secondary | Target IOP | Percentage of participants with IOP of 18 mmHg or Lower, 16 mmHg or Lower, or 14 mmHg or Lower at Any Visit Through Day 28. Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point. | The Per Protocol (PP) population consisted of all subjects in the intention to treat (ITT) population excluding those who made major protocol violations before completing the study. The PP population was considered as the primary analysis population of efficacy (primary and secondary endpoints) of the study. | Posted | Count of Participants | Participants | Up to 28 days |
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-0318 0.006% | PF-0318 0.006% once daily in the evening | 0 | 29 | 2 | 29 | ||
| EG001 | PF-0318 0.024% | PF-0318 0.024% once daily in the evening | 0 | 29 | 3 | 29 | ||
| EG002 | PF-0318 0.04% | PF-0318 0.04% once daily in the evening | 0 | 29 | 5 | 29 | ||
| EG003 | 0.005% Latanoprost | 0.005% latanoprost once daily in the evening | 0 | 30 | 2 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
Contact sponsor directly for details
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 908-300-9920 | susan.harris@bauschhealth.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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| Male |
|
| PF-0318 0.04% |
PF-0318 0.04% once daily in the evening |
| OG003 | 0.005% Latanoprost | 0.005% latanoprost once daily in the evening |
|
|
| PF-0318 0.04% |
PF-0318 0.04% once daily in the evening |
| OG003 | 0.005% Latanoprost | 0.005% latanoprost once daily in the evening |
|
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